Reply #184: What are you missing, you ask? Quite a lot, apparently.

[moc]

Let me spell it out for you. The point is that the safety studies have included an absurdly small number of prepubertal girls. The bodies of young girls are different in many many ways from those of full grown women. Therefore, it is quite possible that they could experience side effects that would not necessarily be apparent in a sample of 18-24yo women.

Let me give you a concrete example which I'm sure you can follow. You've heard of thalidomide, yes? If given to non-pregnant individuals, thalidomide is perfectly safe. Indeed, thalidomide is used today quite safely in non-pregnant populations. If you did a large scale clinical trial which did not include pregnant women, you would not identify any negative side effects of thalidomide. However, you cannot conclude based on the results of such a clinical trial that thalidomide is safe for pregnant women because they were not included in the original sample. Indeed, the effects of thalidomide are so specific, you would not identify negative side effects unless your clinical trial sample included pregnant women during those very specific weeks of pregnancy during which limb formation occurs.

Likewise, the safety data currently available regarding gardasil can only be generalized to populations that do not differ substantially from the population of the original sample. It appears that the original sample was predominantly 18-24yo with numbers of prepubertal girls so few (still awaiting specific data but it looks like no more than 500) as to make it impossible to know if side effects might differ in girls who have not undergone menarche. How do you know that the vaccine might not behave differently in the body of an individual undergoing the rapid hormonal changes associated with puberty? Answer, you don't. As the mother of a 10yo girl, I think I'll wait until there are sufficient data demonstrating efficacy in her age group.

Not so beyond understanding, is it?